SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM— 510(k) K103340

Substantially Equivalent

Harvest Technologies, Corp.

FDA 510(k) clearance K103340 for SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM, Substantially Equivalent on 2010-12-06. Applicant: Harvest Technologies, Corp..

Clearance details

Applicant: Harvest Technologies, Corp.
Product code: Code JQC
Advisory panel: Clinical Chemistry
Date received: 2010-11-15
Decision date: 2010-12-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MA, US

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Adverse events under product code JQC

product code JQC

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.